The present invention is a device and method to design a pessary. Typical pessaries today are vaginal devices, usually made of silicone, and often in the shape of a ring or disk. They are often used as a treatment for pelvic organ prolapse and for stress urinary incontinence, conditions that affect at least 25% of the female population. Pessaries are the non-surgical standard of care for treatment of pelvic organ prolapse and are a common treatment option for stress incontinence. While less common, pessaries may also have additional therapeutic and/or diagnostic functions, such as sensors to measure physiologic parameters including temperature or indicators of ovulation or pre-term labor, modified shape for preventing preterm delivery, or electronic capabilities to stimulate the vaginal wall. The shape, structure and functions of a pessary have remained largely unchanged over time. Problems associated with pessaries are often caused by suboptimal fit resulting in inadequate symptom control, discomfort, bleeding, discharge, vaginal erosions, and difficult removal. Surgery may be the only alternative for a patient who cannot be properly fitted with a pessary.
The previous solutions for determining pessary fit were meant to be as efficient and non-invasive as possible. The most commonly used solution for determining pessary fit was an in-office fitting of fixed sample sizes, in which a clinician fitted sample sizes into the patient and determined the best fit in real time by observation and patient feedback. Another previous solution was the inflatable pessary that could be inserted by the patient and inflated to optimal size. The inflatable pessary proved to be uncomfortable, was often of suboptimal fit, and required more insertion and removal than was desirable to patients.